Assessing Adolescent Use of Nexplanon Over Time

NCT04889079 | Active Not Recruiting

• 1 other identifier: IRB_00142231
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare Nexplanon decision-making, uptake, satisfaction and contraceptive outcomes (continuation, switching, discontinuation) over a 12-month period among adolescents ages 15-18 to adolescents ages 19-24, living in Utah. Data from this study will provide valuable information for clinical and public health offerings, counseling and support for Nexplanon use across stages of adolescence.

Conditions

Contraception

Keywords

adolescents; contraception; contraceptive implant

Outcome Measures

Primary Outcomes (1)

• 12-month contraceptive outcomes

  This outcome measures contraceptive use. The question asks "are you still using the Nexplanon implant that you received", and then the outcomes are either: continuation, switching or discontinuation.

  12-months

Secondary Outcomes (1)

• Contraceptive satisfaction

  12-months

Study Arms (2)

Adolescent females, aged 15-18

Adolescents females aged 15-18, who selected a contraceptive implant to prevent pregnancy.

Behavioral: Contraceptive use (continuation/switching/discontinuation)

Adolescent females, aged 19-24

Adolescents females aged 19-24, who selected a contraceptive implant to prevent pregnancy.

Behavioral: Contraceptive use (continuation/switching/discontinuation)

Interventions

Contraceptive use (continuation/switching/discontinuation) BEHAVIORAL

Assessing contraceptive continuation/switching/discontinuation over 12-months

Adolescent females, aged 15-18; Adolescent females, aged 19-24

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents living in Utah seeking a contraceptive implant at a participating clinic.

You may qualify if:

• Between the ages of 15-24;
• Not currently pregnant;
• Planning to avoid pregnancy for the next 12 months;
• Selecting the contraceptive implant as their contraceptive method of choice;
• Willing to be contacted via email survey 4 times over 12-months

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (4)

• Berlan ED, Richards MJ, Vieira CS, Creinin MD, Kaunitz AM, Fraser IS, Edelman A, Mansour D. Best Practices for Counseling Adolescents about the Etonogestrel Implant. J Pediatr Adolesc Gynecol. 2020 Oct;33(5):448-454. doi: 10.1016/j.jpag.2020.06.022. Epub 2020 Jul 2.

  PMID: 32621879 BACKGROUND

• Sawyer SM, Azzopardi PS, Wickremarathne D, Patton GC. The age of adolescence. Lancet Child Adolesc Health. 2018 Mar;2(3):223-228. doi: 10.1016/S2352-4642(18)30022-1. Epub 2018 Jan 30.

  PMID: 30169257 BACKGROUND

• Downey MM, Arteaga S, Villasenor E, Gomez AM. More Than a Destination: Contraceptive Decision Making as a Journey. Womens Health Issues. 2017 Sep-Oct;27(5):539-545. doi: 10.1016/j.whi.2017.03.004. Epub 2017 Apr 12.

  PMID: 28412049 BACKGROUND

• Diedrich JT, Klein DA, Peipert JF. Long-acting reversible contraception in adolescents: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Apr;216(4):364.e1-364.e12. doi: 10.1016/j.ajog.2016.12.024. Epub 2016 Dec 28.

  PMID: 28038902 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: June 6, 2021
• Primary Completion: December 31, 2024
• Study Completion: May 30, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)